ALPHA THERAPEUTICS' ALPHANINE (FACTOR IX) IS AMONG LATE-1990 BIOLOGICS APPROVALS; CBER CITES 14 OF 62 PRODUCT LICENSES GRANTED IN 1990 AS "IMPORTANT"
Alpha Therapeutics will begin shipping AlphaNine (Coagulation Factor IX human) by February following mandatory FDA clearance of the first lots of the product. AlphaNine was approved by FDA on Dec. 31. The affinity-purified Factor IX product is indicated for the "prevention and control of bleeding in patients with Factor IX deficiency due to Hemophilia B." The PLA for AlphaNine was filed in January 1988. The product represents an improvement over Alpha Therapeutics' heat-treated Factor IX complex (Profilnine) in its reduced incidence of harmful clotting. FDA's Center for Biologics Evaluation and Research ranked AlphaNine among the agency's 14 "important" biologic approvals in 1990. Overall, FDA approved 62 biological product license applications and 23 establishment license applications in 1990, for a total of 85. Last year, the number of biologic licenses issued for products and establishments totalled 113. Coagulation Factor IX offers an advantage over Factor IX complex because the second-generation product has been depleted of Factors II, VII, and X, which are associated with thromboembolic complications. The new preparation contains "less than 5 units each of Factor II (prothrombin) and Factor VII (proconvertin) per 100 IU of Factor IX, and less than 20 units of Factor X," the company said. AlphaTherapeutics plans to charge a premium for its new Factor IX product. The average wholesale price for the affinity purified AlphaNine will be $ 1.15 per unit compared to 35 cents/unit for Profilnine. The AlphaNine price to wholesalers will be 90 cents per unit. Alpha Therapeutics is sending "Dear Doctor" letters, cleared by FDA, to physicians outlining the characteristics and clinical experience of the new Factor IX product. In an open clinical trial, six hemophilia B patients were given 32-65 units/kg of AlphaNine prior to surgery and then 13-50 units/kg as post-surgery replacement therapy. The patients received a total of between 8,110 and 35,350 units in an average of 17 infusions. "No bleeding episodes were reported and hemostasis was maintained during the course of post surgery therapy," the letter notes. In addition, "none of the hematologic parameters examined and provided any evidence that AlphaNine possessed thrombogenic potential." Twelve patients have received a total of 115 infusions in clinical trials with no major adverse events. Approximately 2,800 patients suffer from hemophilia B in the U.S, FDA said in a Jan. 3 press release announcing the approval. Los Angeles-based AlphaTherapeutics was also the beneficiary of a late 1989 approval -- for Fluosol, an oxygen transport fluid used to prevent myocardial ischemia during angioplasty ("The Pink Sheet" Jan. 8, p. 8). Other December approvals by CBER included Ortho's Procrit (Amgen's PLA) for non-dialysis and AZT-induced anemia on New Year's Eve (see story p. 5) and Genentech's Actimmune (interferon gamma-1b), for reducing infection associated with chronic granulomatous disease, on Dec. 20 ("The Pink Sheet" Dec. 24, T&G- 7). On Dec. 13, Merck received approval to expand its indication for its Hemophilus b conjugate vaccine PedvaxHIB to two month-old infants. With PedvaxHIB, infants are immunized at two, four and 12 months. Lederle-Praxis was the first to receive approval of the indication for its HibTITTER in October ("The Pink Sheet" Oct. 8, T&G-1). The schedule of vaccination with HibTITTER is two, four, six and 15 months. The third marketed Hemophilus b vaccine, Connaught's ProHIBIT, has yet to be approved for the indication. Connaught, however, received approval for another important biologic in May ("The Pink Sheet" May 28, T&G-7). Connaught's TheraCys (Bacillus Calmette Guerin Live) was approved on May 21 as the first treatment for carcinoma-in-situ of the urinary bladder. Organon Teknika's BCG tuberculosis vaccine (Tice BCG) received approval for the same indication on Aug. 24. The Organon vaccine, marketed by sister company Organon Inc., differs from BCG live in its administration, requiring only one ampule of 50 mg to TheraCys' three vials. Institute Merieux' inactivated poliovirus vaccine injectable received approval on Dec. 21 for the immunization of infants, children and adults. The product will be manufactured in Lyon, France and marketed by Connaught beginning late in the second quarter. Connaught plans to discontinue marketing of its IPV vaccine, manufactured in Toronto. Cytomegalovirus immune globulin intravenous, which became the first product distributed under a Treatment IND in October 1987, was approved in April for attention of primary CMV disease associated with kidney transplant ("The Pink Sheet" Apr. 23, T&G- 5). The product is distributed by Massachusetts Public Health Biologic Laboratories. Another biologic reportedly close to approval is Schering's Intron A for the treatment of Hepatitis C (non-A, non-B). FDA's Biological Response Modifiers Advisory Committee recommended approval of Intron A for that use in July ("The Pink Sheet" Aug. 6, p. 11). Overall in 1990, the agency accepted 492 license amendments, of which 355 were product amendments. Eighty-three licenses were either revoked or withdrawn this year.
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